6935 Sprint Quattro Secure S
Defibrillation
6935 Sprint Quattro Secure S
ALL
Information

Device Survival Probability

6935_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 114.0 mo
% Survival 99.5 99.2 98.9 98.6 98.4 98.0 97.4 96.8 95.3 95.3
#   2346 1882 1501 1170 951 765 493 254 114 66

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2734
Cumulative Months of Follow-Up 129726
Number of Leads Active in Study 893
Information 49

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 18
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 6
Lead Dislodgement 7
Oversensing 7
Other 1
Unspecified Clinical Failure 1
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 24
Conductor Fracture 3
Extra Cardiac Stimulation 1
Failure to Capture 27
Failure to Sense 12
Impedance Out of Range 25
Insulation Breach 1
Lead Dislodgement 58
Oversensing 61
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2008-11-01
CE Approval Date2008-03-31
Registered USA Implants61326
Estimated Active USA Implants46450
US Market Release2008-11-01
CE Approval Date2008-03-31
Estimated WW Distribution176134
Information

USA Returned Product Analysis

Conductor Fracture 355
Insulation Breach 11
Crimp/Weld/Bond 0
Other 41
Information

WW Returned Product Analysis

Conductor Fracture 712
Insulation Breach 28
Crimp/Weld/Bond 0
Other 72
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Active Screw In
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar/One Coil
More
Serial Number Prefix TAU
Lead Body Diameter 8,2 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of April 10, 2020

www.medtronic.com/productperformance 751050